MAXITRAM SR 200MG PROLONGED-RELEASE CAPSULES

Transcript

567_FR02148_V6_MAXITRAM_567_FR02148_V6 22/06/15 08:28 Page1

Package Leaflet: Information for the user

MAXITRAM SR 50 mg, 100 mg, 150 mg and 200 mg
prolonged-release capsule, hard
Tramadol hydrochloride
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor, pharmacist or nurse.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
 If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What MAXITRAM SR is and what it is used for
2. What you need to know before you take MAXITRAM SR
3. How to take MAXITRAM SR
4. Possible side effects
5. How to store MAXITRAM SR
6. Contents of the pack and other information
1. WHAT MAXITRAM SR IS AND WHAT IT IS USED FOR
Tramadol hydrochloride - the active substance of MAXITRAM SR - belongs to a group of medicines
known as opioid analgesics or painkillers. Its pain-relieving action is due to its effect on specific
nerve cells in the spinal cord and brain.
MAXITRAM SR is used in the treatment of moderate to severe pain.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MAXITRAM SR
Do not take MAXITRAM SR:
 if you are allergic to tramadol or any of the other ingredients of this medicine (listed in section 6)
 if you are intoxicated with alcohol or with sedative drugs including sleeping pills, other
painkillers or tranquiliser medicines
 if you are taking, or have taken in the last two weeks, certain medicines called “monoamine
oxidase inhibitors” or MAOIs (used to treat depression). The combination could result in a
serious, potentially life threatening interaction.
 if you have epilepsy that is not controlled with your current medicine
MAXITRAM SR is not suitable as a drug substitute for the treatment of drug addiction.
MAXITRAM SR is not suitable for use in children under 25 kg body weight.
MAXITRAM SR is contraindicated in children below 12 years of age.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking MAXITRAM SR:
 if you suffer from epilepsy or seizures (fits) or have had them in the past, because tramadol
could increase the risk of you having further fits.
 if you have liver or kidney problems.
As with all opioids, tramadol should be used with caution, and only under medical supervision in
seriously ill patients including those with impaired breathing, excessively low blood pressure
(shock), serious head injury or brain diseases that may cause elevated pressure in the skull.
As with all opioids, tramadol may lead to psychological and physical dependance or addiction in
some people, especially with long term use. The dose needed to achieve the desired effect may
increase with time. Tramadol should be used with caution, and only for short periods in patients
who are addicted to other opioid painkillers.
Other medicines and MAXITRAM SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The pain-relieving effect of MAXITRAM SR may be weakened and/or shortened if you also take
medicines containing:
 carbamazepine (used to treat epilepsy)
 pentazocine, nalbuphine or buprenorphine (pain killers)
 ondansetron (used to stop you feeling sick)
The risk of side effects increases:
 if you are taking medicines which may cause convulsions (fits), such as certain antidepressants or
antipsychotics. The risk of having a fit may increase if you take MAXITRAM SR at the same time.
Your doctor will tell you whether MAXITRAM SR is suitable for you.
 if you are taking certain antidepressants. MAXITRAM SR may interact with these medicines and
you may experience symptoms such as involuntary, rhythmic contractions of muscles, including
the muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration
of reflexes, increased muscle tension, body temperature above 38oC.
 if you take MAXITRAM SR at the same time as sedative medicines such as tranquilisers, or
sleeping pills, and other pain relievers (morphine, codeine). You may feel excessively drowsy or
feel that you might faint.
 if you take MAXITRAM SR at the same time as alcohol. Tramadol may increase the intoxicating
effect of alcohol and therefore you should be cautious if you wish to drink alcohol during treatment
with MAXITRAM SR.
 if you take MAXITRAM SR at the same time as medicines that inhibit blood clotting, such as
warfarin. The dose of these medicines may need to be reduced, otherwise there could be an
increased risk of potentially serious bleeding.
Do not take MAXITRAM SR at the same time as medicines called “monoamine oxidase
inhibitors” (which are used to treat depression), or if you have taken one in the past 2 weeks.
Pregnancy and breast-feeding
MAXITRAM SR may affect an unborn child and is present in breast milk. Therefore it should not
be taken during pregnancy or breast-feeding.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your
doctor or pharmacist for advice before taking this medicine.
Driving and using machines
MAXITRAM SR may cause side effects such as drowsiness and blurred vision. If this happens,
do not drive or use any tools/machines and do not perform any hazardous tasks.
The medicine can affect your ability to drive as it may make you sleepy or dizzy.
 Do not drive while taking this medicine until you know how it affects you.
 It is an offence to drive if this medicine affects your ability to drive.
 However, you would not be committing an offence if:
 The medicine has been prescribed to treat a medical or dental problem and
 You have taken it according to the instructions given by the prescriber or in the information
provided with the medicine and
 It was not affecting your ability to drive safely
Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while taking
this medicine.
MAXITRAM SR contains benzoates and sucrose
This medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may
cause allergic reactions, some of which may be delayed.
This medicine contains sucrose. If you have been told by your doctor that you have an intolerance
to some sugars, contact your doctor before taking this medicine.
3. HOW TO TAKE MAXITRAM SR
The dosage should be adjusted to the intensity of your pain and your individual pain sensitivity.
In general the lowest pain-relieving dose should be taken.
Always take MAXITRAM SR exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
The usual doses are given below. Your doctor may gradually increase or decrease your dose
depending on how you respond to treatment.

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Adults and adolescents aged 12 and over:
50 mg capsules:The usual dose is two to four 50 mg capsules taken twice a day, equivalent to 200 to
400 mg per day.
100 mg capsules:The usual dose is one to two 100 mg capsules taken twice a day, equivalent to 200
to 400 mg per day.
150 mg capsules:The usual dose is one 150 mg capsule taken twice a day, equivalent to 300 mg per
day.
200 mg capsules:The usual dose is one 200 mg capsule taken twice a day, equivalent to 400 mg per day.
The capsules should be taken in the morning and evening.You should not normally take more than
400 mg a day.
Use in children:
This medicinal product is not suitable for use in children below 25 kg body weight which in general
does not allow for individualized dosage in children below 12 years of age. Other form(s) of this
medicine may be more suitable for children; ask your doctor, pharmacist or nurse.
Elderly patients:
In elderly patients (above 75 years) the excretion of tramadol may be delayed. If this applies to you,
your doctor may recommend prolonging the dosage interval.
Severe liver or kidney disease (insufficiency)/dialysis patients:
Patients with severe liver and/or kidney problems, should not take MAXITRAM SR. If in your case
the insufficiency is mild or moderate, your doctor may recommend prolonging the dosage interval.
Route and method of administration
For oral use.
The capsules should be swallowed whole with a glass of water.
The capsules can be taken with or without food. They should NOT be chewed or crushed.
If you take more MAXITRAM SR than you should
If high doses are taken accidentally, you should contact your doctor immediately or go to your
nearest hospital casualty department. A number of symptoms may occur. These might include:
vomiting (being sick), a fall in blood pressure, a fast heartbeat, collapse, fainting or even coma,
epileptic fits and difficulties in breathing.
If you forget to take MAXITRAM SR, take it as soon as you remember and then carry on as before.
Do not take a double dose to make up for a forgotten dose.
If you stop taking MAXITRAM SR, your pain may return.
If you would like to stop treatment because you have unpleasant side effects, please talk to your
doctor. If you have been taking this medicine for a very long time, you may get the following side
effects if you suddenly stop treatment: restlessness, anxiety, nervousness, shaking or an upset
stomach. If you get any of these effects after stopping treatment with MAXITRAM SR please talk to
your doctor.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
MAXITRAM SR can occasionally cause allergic reactions although serious allergic reactions
(including anaphylaxis and angioedema) are rare. Tell your doctor immediately if you get any
sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching
(especially affecting your whole body).
The following side effects may occur:
Very common: may affect more than 1 in 10 people
• Nausea (feeling sick)
• Dizziness
Common: affects up to 1 in 10 people
• Headache
• Drowsiness
• Vomiting (being sick)
• Dry mouth
• Constipation
• Sweating
• Fatigue (tiredness)
Uncommon: affects up to 1 in 100 people
• Palpitations (quicker or irregular heartbeat)
• Retching
• Increased heartbeat
• Diarrhoea
• Weakness
• Stomach bloating
• Low blood pressure, especially when
• Skin disorders (e.g. itchiness, rash, sudden
standing upright
onset of skin redness)
Rare: affects up to 1 in 1,000 people
• Slow heartbeat (bradycardia)
• Mood changes
• Rise in blood pressure
• Hallucinations
• Changes in appetite
• Confusion
• Abnormal skin sensations (e.g. pins and
• Difficulty sleeping
needles, numbness)
• Anxiety
• Trembling
• Nightmares
• Breathing difficulties
• Blurred vision
• Epileptic-like seizures (“fits”)
• Reduced muscle strength
• Muscle twitches
• Urinary disorders e.g. producing less urine
• Fainting
than normal
• Uncoordinated movement
• Drug dependance (addiction)
• Generalised allergic reactions (see above)
Very rare: affects up to 1 in 10,000 people
• Increased level of liver enzymes
Not known: Frequency cannot be estimated from the available data
• Decrease in blood sugar level (hypoglycaemia)
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist, or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on
the safety of this medicine.
5. HOW TO STORE MAXITRAM SR
Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry
date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of
that month. Do not store above 25°C. Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will
help to protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What MAXITRAM SR contains
The active substance is tramadol hydrochloride. Each capsule contains 50 mg, 100 mg, 150 mg or
200 mg of tramadol hydrochloride equivalent to 43.91 mg, 87.82 mg, 131.73 mg or 175.64 mg
tramadol.
The other ingredients are:
 Sugar spheres (maize starch and sucrose)
 Macrogol 4000
 Polyacrylate dispersion 30% (ethyl acrylate, methyl methacrylate, nonoxynol)
 Dimeticone emulsion (dimeticone, (t-octylphenoxy) polyethoxyethanol, Macrogol 600,
polyethylene-sorbitan-monolaurate, sodium benzoate, propyl-4-hydroxybenzoate (E216),
methyl-4-hydroxybenzoate (E218), propylene glycol, sorbic acid)
 Hypromellose
 Talc  Gelatin
 Titanium dioxide (E 171)
 Yellow iron oxide (E172) [100 mg, 150 mg, 200 mg capsules only]
What MAXITRAM SR looks like and contents of the pack
All strengths of MAXITRAM SR capsules contain white spherical microgranules (“beads”)
50 mg gelatin capsules are white opaque
100 mg gelatin capsules have an opaque yellow cap and natural transparent body
150 mg gelatin capsules are opaque yellow
200 mg gelatin capsules have an opaque yellow cap and opaque white body
Pack sizes: 10, 20, 28, 30, 50, 56, 60, 100 capsules. Hospital packs: 500 capsules
Not all pack sizes may be marketed
Marketing Authorisation Holder and Manufacturer
Chiesi Limited, 333 Styal Road, Manchester, M22 5LG, UK.

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This leaflet was last revised in: 07/2015

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.